Effects of Hypothermia on Delayed Neurocognitive Recovery (DNR): an Observational Trial Among Patients Undergoing Cardiac-Surgery

University of Padova168 enrolled

Overview

Post-operative cognitive dysfunction is a common disease in patient undergoing general anaesthesia, especially in older patients. No correlations have been yet studied between intraoperative hypothermia and incidence of Delayed Neurocognitive Recovery. Investigators are going to estimate the Relative Risk of Hypothermia and emergence of Post-operative cognitive dysfunction in cardiac-surgery patients.

Study Type

OBSERVATIONAL

Enrollment

168

Conditions

Cognitive Dysfunction Emergence Delirium Hypothermia

Interventions

Hypothermia during Extracorporeal CirculationPROCEDURE

Normothermia during Extracorporeal Circulation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Adults patients undergoing Cardiac - Surgery intervention with extracorporeal circulation Exclusion Criteria: * Neurological disease before surgery * Sedation in Cardiac-Surgery Intensive Unit \> 6 hours * Cerebral regional Oxygen saturation \<20% baseline during surgery

Locations (1)

Università degli Studi di Padova

Padua, PD, Italy

Outcomes

Primary Outcomes

Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery

Discover changes between pre-operative general cognition tests (Montreal Cognitive Assessment and Short Portable Mental Status Questionnaire) test score and post-operative Montreal Cognitive Assessment test score.

Time frame: Patients will be subjected to Montreal Cognitive Assessment and Short Portable Mental Status Questionnaire test one day before surgery and 4-6 days after surgery

Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery

Discover changes between pre-operative Trail Making Test A and B score and post-operative Trail Making Test A and B score.

Time frame: Patients will be subjected to Trail Making Test A and B one day before surgery and 4-6 days after surgery

Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery

Discover changes between pre-operative Digit Span Test score and post-operative Digit Span Test score.

Time frame: Patients will be subjected to Digit Span Test one day before surgery and 4-6 days after surgery

Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery

Discover changes between pre-operative Frontal Assessment Battery test score and post-operative Frontal Assessment Battery test score and

Time frame: Patients will be subjected to Frontal Assessment Battery test one day before surgery and 4-6 days after surgery

Secondary Outcomes

Effects of hypothermia during Extracorporeal Circulation in Cardiac Surgery

Discover statistical significance difference in incidence of Post-Operative Cognitive Decline between patients undergoing normothermia and patients undergoing hypothermia during Extracorporeal Circulation in Cardiac Surgery

Time frame: One day before surgery and 4-6 days after surgery patients will be subjected to cognitive test to diagnosticate Post-Operative Cognitive Decline

Data from ClinicalTrials.gov

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